FIRST BXN Mouthwash

CutisPharma, Inc
Marlex Pharamceuticals, Inc

FULL PRESCRIBING INFORMATION: CONTENTS*

• FIRST BXN MOUTHWASH DESCRIPTION
• How Supplied and Compounding Directions

FULL PRESCRIBING INFORMATION

FOR PRESCRIPTION COMPOUNDING ONLY

FIRST BXN MOUTHWASH DESCRIPTION

Each FIRST^®- BXN Mouthwash Compounding Kit is comprised of 0.2 grams of diphenhydramine hydrochloride powder USP, 1.6 grams of lidocaine hydrochloride powder USP, and 1.6 grams of nystatin powder USP for oral use.Certificate of analysis on file FIRST^®- BXN Mouthwash Compounding Kit also contains a 236 mL suspension containing benzyl alcohol, carboxymethycellulose sodium, citric acid (anhydrous), dehydrated alcohol, FD&C yellow #5, flavors, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate (dihydrate), and sorbitol solution. When compounded, the final product provides an homogeneous suspension containing diphenhydramine hydrochloride, lidocaine hydrochloride, and nystatin comparable to the active ingredients (Benadryl^®, Xylocaine^® 2% Viscous and Nystatin Oral Suspension 1:1:1 v/v/v) contained in Magic Mouthwash with Nystatin .This product is not manufactured by Pfizer, Inc., manufacturer of Benadryl^® or by AstraZeneca LP, manufacturer of Xylocaine^® 2% Viscous.

How Supplied and Compounding Directions

TO THE PHARMACIST

Everything you need to make this Rx is included...

1 . FlRST^®-Mouthwash BXN Compounding Kit contains premeasured diphenhydramine hydrochloride powder, lidocaine hydrochloride powder, nystatin powder, and mouthwash suspension II.

2 . Important - Before dispensing, tap the top and bottom of the bottle containing diphenhydramine hydrochloride to loosen the powder and remove the cap. Empty the diphenhydramine hydrochloride powder into the bottle containing the mouthwash liquid suspension. Likewise, tap the top and bottom of each of the bottles containing the lidocaine hydrochloride and nystatin powders, remove the caps and empty the lidocaine hydrochloride powder and the nystatin powder into the bottle containing the mouthwash liquid suspension. The appropriate quantities of diphenhydramine hydrochloride, lidocaine hydrochloride powder, and the nystatin powder have been packaged in each bottle to deliver the required dosage of each drug. Residual quantities remaining in the bottles after emptying need not be rinsed out.

3 . Close the bottle and shake for 20 to 30 seconds. Instruct the patient to shake bottle well before each use.

Prior to compounding, store FIRST^®- BXN Mouthwash Compounding Kit at room temperature not to exceed 25°C (77°F). Store final compounded formulation at refrigerated temperature, 2°-8°C (36°-46°F) [see USP].

FIRST^®- BXN Mouthwash Compounding Kit components have a two-year expiration date.Data and documentation on file Based on real time refrigerated temperature testing, compounded FIRST^®- BXN Mouthwash Compounding product is stable for at least fifteen days.Data and documentation on file

Mouthwash suspension II meets the requirements for total aerobic microbial count of not more than 100 cfu/mL, as well as for the absence of the specified microorganisms Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Salmonella ssp . when tested as described in the current USP under <61> Microbial Enumeration Tests and <62> Tests for Specified Microorganisms. Mouthwash Suspension II also meets the requirements as described in the current USP under <51> Antimicrobial Effectiveness Testing for Category 2 and Category 3 products.

For oral use only. Avoid contact with eyes. Keep container tightly closed. Keep out of the reach of children. Protect from light. Protect from freezing. Compounded product, as dispensed, is stable for at least 15 days at refrigerated temperature .

Rx ONLY

Issued: June 2009

U.S. Patent Pending

Distributed By:

CP CUTISPHARMA, INC.

SMART PRODUCTS FOR SMART PEOPLE^®

Woburn, MA 01801, USA www.cutispharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - FIRST Mouthwash BXN, 237 mL

NDC 65628-051-01

Rx ONLY

FIRST BXN Mouthwash
Diphenhydramine, Lidocaine, and Nystatin Compounding Kit

Equivalent to active ingredients (Benadryl^®, Xylocaine^® 2% Viscous and Nystatin Oral Suspension 1:1:1 v/v/v) contained in Magic Mouthwash with Nystatin^*

FOR PRESCRIPTION COMPOUNDING ONLY

8 FL OZ (237 mL) as dispensed

^* This product is not manufactured or distributed by Pfizer, Inc., manufacturer of Benadryl^® or AstraZeneca LP, manufacturer of Xylocaine^® 2% Viscous

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - FIRST Mouthwash Suspension II, Bottle 236 mL

FIRST^® - BXN Mouthwash

FOR PRESCRIPTION COMPOUNDING ONLY

Distributed by:
CUTISPHARMA, INC.
Woburn, MA 01801 USA

Manufactured by:
ANI PHARMACEUTICALS, INC.
Gulfport, MS 39501 USA

NET CONTENTS
236 mL

ORAL SUSPENSION

CUTISPHARMA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Diphenhydramine Hydrochloride, Bottle 0.2 Grams

FIRST^® - BXN Mouthwash

FOR PRESCRIPTION COMPOUNDING ONLY

Diphenhydramine Hydrochloride USP (0.2 g)

Distributed by:
CUTISPHARMA, Inc.
Woburn, MA 01801 USA

Repackaged by:
MARLEX PHARMACEUTICALS, INC.
New Castle, DE 19720 USA

CUTISPHARMA
ORAL SUSPENSION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Lidocaine Hydrochloride, Bottle 1.6 Grams

FIRST^® - BXN Mouthwash

FOR PRESCRIPTION COMPOUNDING ONLY
Lidocaine Hydrochloride USP (1.6 g)

Distributed by:
CUTISPHARMA, INC.
Woburn, MA 01801 USA

Repackaged by:
MARLEX PHARMACEUTICALS, INC.
New Castle, DE 19720 USA

CUTISPHARMA
ORAL SUSPENSION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Nystatin, Bottle 1.6 Grams

FIRST^® - BXN Mouthwash

FOR PRESCRIPTION COMPOUNDING ONLY
Nystatin USP (1.6 g)

Distributed by:
CUTISPHARMA, INC.
Woburn, MA 01801 USA

Repackaged by:
MARLEX PHARMACEUTICALS, INC.
New Castle, DE 19720 USA

CUTISPHARMA
ORAL SUSPENSION